04. December 2020 - 1:00 till 2:30
Online
0Online

Managing Projects in the Life-Science Industry, Online, Friday, 04. December 2020

The Increasingly Important Role Of Project Manager In Life Sciences

About this Event

A new product launch, a clinical study, or regulatory submission are all examples of projects in life sciences.

In performing their jobs, PMs in the life sciences are taking on more cross-functional responsibilities. And while asked to wear many hats, they must still ensure the final product or program is delivered on time, within budget, and in compliance.

Our experienced panelists will share their knowledge and tips on how to drive and successful complete projects in all phases of the life sciences industry


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Carl Albertson has over 30 years of diversified experience in engineering and project management in the biotech, aseptic and pharmaceutical processing industry. His experience ranges through all phases of project design including design, construction, commissioning and qualification. He is currently a Director in the capital projects department at BioMarin in Novato, CA. BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions with focus on rare (orphan) genetic diseases. Carl was the overall project manager responsible for all facets of the newly and state of the art gene-therapy manufacturing plant project of BioMarin


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Lori Chelemedos (Panel Moderator) is the CEO and principal consultant at Pac-Side LLC, a management consulting firm specializing in regulatory compliance, quality systems and business process improvement projects in the pharmaceutical industry.

Previously, she was the Associate Director of GxP Inspection Management at BioMarin partnering with senior leadership, middle management, and subject matter experts (SMEs) to prepare for and support Health Authority inspections. She also worked as a Technical Senior Manager in the Global Quality Inspection Management department at Roche/Genentech supporting the Americas, APAC, and Europe with Health Authority inspection readiness/execution including various process improvement projects. She also held roles at Roche/Genentech in IT, Production, and Quality either leading or participating in the improvement of business processes and technology.

Previous to entering the biotechnology field, she performed business process and technology work in the semi-conductor, telecommunications, energy, shipping, and apparel industries with a focus on Manufacturing, Supply Chain, and Quality operations. Lori holds Master of Business Administration from Golden Gate University, a Certificate in Quality and Compliance from UC Berkeley, is trained in APICS, Lean, and Six Sigma, and is currently pursuing a Doctor of Business Administration at Golden Gate University.





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Heike Abeck (PE, PMP) is currently Director of MSAT, Analytical Methods at Bayer in


Berkeley, CA. She has over 20 years experience in the biotech industry, starting as a


process engineer with Bechtel and then moved into manufacturing as a specialist with


Chiron.

She held positions of increasing responsibility at Chiron in Engineering, Capital


Projects, and Chemistry Manufacturing & Controls (CMC) Project Management,


ultimately responsible for managing cross-functional process development teams


through the clinical product development lifecycle.

After Novartis acquired Chiron, she


spent two and a half years on a global assignment with the Sandoz division of Novartis


in Austria on several BioSimilars. Upon return from Austria, she worked as Associate

Director of Project and Portfolio Management at Novartis Diagnostics and then as


Director of Manufacturing Sciences and Technology. After Grifols acquired Novartis


Diagnostics, Heike moved to Bayer in Berkeley leading the validation and submission of


the next generation Factor VIII product Jivi. Heike then moved to Germany to support


the transfer of Factor VIII production to Bayer, Wuppertal. Unfortunately, this project


was discontinued and Heike is back in Berkeley heading up the MSAT Analytical


Methods team focusing on optimizing, transferring and troubleshooting QC release


testing methods.

Heike received a BS in Chemical Engineering from UC Berkeley and a combined MS in


Engineering Project Management and Technology Management from Berkeley


Engineering and Haas School of Business. She is a member of PMI, International


Society of Pharmaceutical Engineers (ISPE), co-led the German American Business


Association (GABA), and was on the board of the Bay Area Kinderstube, BAKS+.

Heike is an avid cyclist, surfer, and ultimate frisbee player and enjoys spending time


with her husband, 13 and 7 year old sons.


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Stephen Smith is currently the Senior Director for Project Excellence at Clovis Oncology and leads the project team for one of the company’s assets. Prior to joining Clovis, Stephen has led drug development and life cycle teams for Audentes Therapeutics, Medivation, Genentech, Gilead Sciences, and Elan Pharmaceuticals, working in oncology, gene therapy, virology, and neurology. Stephen earned a Master’s of Science in Project Management with high honors and a Master’s in Business Administration with highest honors from Golden Gate University and a Master’s of Art in East Asian Art with distinction from the Sotheby’s Institute of Art London. To maintain his passion for art and lifelong learning, he currently serves on the Golden Gate University Alumni Board of Directors and curating an art auction to support the mission of Access Institute in San Francisco.




Platinum Annual Partners:
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more info at www.gene.com



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more info at www.cagents.com




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more info at www.govzilla.com




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more info at www.merck.com





Titanium Annual Partners:
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more info at pacelabs.com





Bronze Sponsor:
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more info at www.analyticallabgroup.com





FAQs

How can I contact the organizer with any questions?

You can contact the event organizer sending an email to email, please allows few days for the response, emails will not be monitored on the day of the event.


What are my transporation/parking options?

The event venue is located in Downtown San Francisco, 1min. walking from the Embarcadero BART.

In case you will be driving, please plan your commute ahead of time, considering there could be traffic getting into San Francisco and difficulties to find street parking.

We are not affiliated or endorse any parking garage, however here a map of parking spaces that close at 22:00 nearby our event venue. Please check the time and rates ahead of time as they might change and we do not check them (i.g. #3 Golden Gateway on 250 Clay St rate is $1/hr after 6pm until close, 10pm):


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Warning: there might be other garages nearby, however they might close earlier than our event ending.


How can I access the event venue?


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Who can I contact if I am not able to locate the event venue and/or I cannot access the building?

If you need support on the day of the event for building access or location call 6502968044


Is my registration fee or ticket transferable?

Yes, you can transfer it by 08JUN20 to whoever would like to attend in your behalf. Ticket is not reimbursable


My company would like to become a WCC PDA Sponsor, do you have a sponsorship program?

Yes, our offers a unique opportunity for companies that want to strengthen brand image, increase visibility, and gain access to leaders of the San Francisco Bay Life-Science Community


What is the dressing code?

Business casual




Cancellation Policy:

Dinner seating is confirmed and reserved in advance. We regret that no refunds can be offered for non-attendance. If a registrant cannot attend, substitutions are welcome by 08JUN20. The chapter reserves the right to cancel a dinner meeting if the minimum number of attendees is not met by Monday prior to the event. The chapter reserves the right to not answer emails or phone calls on the day of the event


Privacy Policy:

We manage your personal data responsibly and align with PDA privacy policy.

REGISTRATION AGREEMENT: by registering to this event I consent the WCC PDA to record and/or photograph me and using those recording and/or photographs in the future WCC PDA promotional and marketing material, and to send me promotional information via email.


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Joe Yee is Director, CMC Project Management at Sangamo Therapeutics, where he is responsible with his team for the delivery of products in support of early and late phase clinical programs, and for inventory management, clinical supply chain and risk planning.

Prior to this role Joe worked at Novartis Vaccines and Diagnostics were he led roles of increasing responsibilities from manufacturing to the Technical Operations Project Management Office.

Joe hold a Bachelor degree in Biochemistry from UC Davis


Friday, 04. December 2020, Online, Managing Projects in the Life-Science Industry

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